# China NMPA Product Recall - Blood glucose test strips (glucose dehydrogenase method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/112d0358-c32c-4059-aad6-40f4e60499a7/
Source feed: China

> China NMPA product recall for Blood glucose test strips (glucose dehydrogenase method) by Roche Diagnostics Products (Shanghai) Co., Ltd. published July 30, 2021. Recall level: Level 2 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. has initiated a voluntary Class II recall of its blo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its blood glucose test strips (glucose dehydrogenase method).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2021-07-30
- Product Name: Blood glucose test strips (glucose dehydrogenase method)
- Recall Level: Level 2 Recall
- Recall Reason: In rare cases, the test strip tubes inside the sealed cardboard box may accidentally open during transportation. The existing product manuals lack sufficient guidance on how to handle accidentally opened test strip tubes inside the sealed cardboard box.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: Roche Diagnostics Products (Shanghai) Co., Ltd. has initiated a voluntary Class II recall of its blood glucose test strips (glucose dehydrogenase method), as announced by the National Medical Products Administration (NMPA) on July 30, 2021. The recall stems from the rare occurrence of accidental openings in the test strip cartridges during transportation, coupled with a lack of comprehensive guidance within the existing product instructions on how to manage such incidents. This issue affects specific models and batches of the test strips, identified by Registration Certificate Nos. 20162402313 and 20162402312. The company's proactive measure underscores its commitment to product quality and patient safety, ensuring that users have appropriate instructions for handling their medical devices. Further details regarding the affected products are available in the accompanying "Medical Device Recall Event Report Form" referenced by NMPA Index No. JGXX-2021-10414. This action ensures compliance with regulatory expectations for medical device manufacturers in China.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-products-shanghai-co-ltd/9b830c5b-8305-4f55-9e76-759151e7c7a9/